| CTRI Number |
CTRI/2024/06/068590 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to find the effective dose of sugammadex to reverse the eefectbof muscle relaxants in patients undergoing General Surgery receiving muscle relaxants in general anesthesia |
|
Scientific Title of Study
|
Comparative Study for the Efficacy of Sugammadex 1mg/kg and 2mg/kg for the Reversal of Neuromuscular blockade after Vecuronium for patients undergoing Elective surgery Under General Anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya S Goudar |
| Designation |
Postgraduate student MD Anaesthesiology VIMS Ballari |
| Affiliation |
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES BALLARI |
| Address |
Department of Anesthesiology VIMS Ballari, VIMS OT Complex
Bellary
KARNATAKA
583104
India |
| Phone |
8618545060 |
| Fax |
|
| Email |
goudarkavya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavya S Goudar |
| Designation |
Postgraduate student MD Anaesthesiology VIMS Ballari |
| Affiliation |
VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES BALLARI |
| Address |
Department of Anaesthesiology, Vims OT Complex, VIMS Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
8618545060 |
| Fax |
|
| Email |
goudarkavya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasalu |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences. |
| Address |
Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences,Cantonment,Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar Institute of Medical Sciences Ballari, Karnataka, India -583104 |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences Ballari, Cantonment, Ballari ,Karnataka, India 583104 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavya S Goudar |
Vijayanagar Institute of Medical Sciences ballari |
Department of Anaesthesiology Major OT Complex,Cantonment Bellary 583104
Bellary
KARNATAKA |
8618545060
goudarkavya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vims Institutional Ethic Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sugamadex |
Sugamadex 1mg/kg will given at TOF Count 2 in one group till TOF count reaches 0.9, and sugamadex 2mg/kg will be given at TOF count of 2 in another group till TOF count reaches 0.9 and patient will be observed till he recovers from muscle paralysis |
| Comparator Agent |
Sugammadex |
Sugammadex 1mg/kg in one group at TOF count 2 and Sugammadex 2mg/kg at TOF count 2 in other group every 2minutes till TOF count reaches 0.9 and patient will be observed for two hours after last dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients included under ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Renal dysfunction
2. Allergic to muscle relaxants
3. Pregnant females, breastfeeding females
4. History of chronic obstructive pulmonary disease |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. The response to train - of - four stimulation just before sugammadex administration |
Muscle power,level of consciousness after extubation for 2minutes, 5minutes,10minutes,30minutes ,60minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The incidence of recurrent paralysis during the postoperative monitoring period |
15minutes, 30minutes,1hour after reversal |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After preoperative anaesthetic evaluation on the day of admission, the patients satisfying the criteria for selection will be explained about the procedure and consent will be obtained. Patient’s nil per oral status 6hrs for solids, 2 hours for liquids will be confirmed and shifted inside the operation theatre. The standard monitors will be connected and basal physiological parameters will be measured and mechanosensor based on kinemyography (TOF,GE healthcare) NM T will be attached to thumb and index finger of the patient and one brown electrode is placed on ulnar side 2cm below wrist joint and other white electrode is placed2cm below the 1st electrode. The mechanosensor measures the motion or the thumb with a piezoelectric sensor,which converts the physical motion to an electrical signal and quantifies the evoked mechanical response. The maximum twitch response will be noted. The patient will be given premedication with Inj Glycopyrrolate0.01 mg/kg, Inj Fentanyl 2mcg/kg, then preoxygenated with 100% oxygen for 3 minutes followed by Intravenous induction with Inj Propofol 2mg/kg and before administration of Inj Vecuronium 0. Img/kg. Repititve train-of-ratio(TOF)stimulation will be applied at ulnar nerve at the wrist every 15s until the end of anaesthesia or atleast until recovery of the TOF ratio().9. Body temperature will be maintained at ?35.0 0 C. Tracheal intubation will be performed after onset of complete blockade. Maintainence with Oxygen:Air/N20 according to the patient need and inj Vecuronium 0.020.03mg/kg administered as needed at reappearance of second twitch(T2) of the TOF if clinically required. At reappearance of T2 after last dose of vecuronium, Sugammadex I mg/kg in one group and 2m/kg in other group will be administered. After the TOF ratio >().9 tracheal extubation will be done. The assessments includes the level of consciousness (awake and oriented, arousable with minimal stimulation, or responsive only to tactile stimulation), muscle strength (ability to independently transfer from surgery table to bed, head tilting, and hand squeezing), and a 5-s head lift test. The respiratory frequency and pattern of the patient will be monitored and pulse oximetry will be performed in the PACU for at least 2 hours after the recovery of the TOF ratio to 0.9.
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